FDA Medical devices recall · July 9, 2025

Valeda Light Delivery System Product Name: Light Based Device for Dry Age… recall

Read the official FDA notice ↗

Product

Brand Name: Valeda Light Delivery System Product Name: Light Based Device for Dry Age Related Macular Degeneration Product Description: Light Based Device for Dry Age Related Macular Degeneration Component: No

Why was it recalled?

U.S. customers were shipped devices that were configured for the European Union and were unable to plug the device in the electrical outlet.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot Code: UDI-DI +B749200001030/$$+720172/16D20250311T; Serial Number 20172 UDI-DI +B749200001030/$$+720166/16D20250311W; Serial Number 20166 UDI-DI +B749200001030/$$+720167/16D20250311X; Serial Number 20167 UDI-DI +B749200001030/$$+720168/16D20250311Y; Serial Number 20168 UDI-DI +B749200001030/$$+720169/16D20250311Z; Serial Number 20169 UDI-DI +B749200001030/$$+720175/16D20250311W; Serial Number 20175 UDI-DI +B749200001030/$$+720177/16D20250311Y; Serial Number 20177 UDI-DI +B749200001030/$$+720178/16D20250311Z; Serial Number 20178 Update 14 May 2025: UDI-DI +B749200001030/$$+720170/16D20250311R; Serial Number 20170

Distribution

US Nationwide distribution in the states of AZ, CA, FL, IL, ND, TN, TX.

States: Arizona California Florida Illinois North Dakota Tennessee Texas

What does Class III mean?

Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).

Source: FDA (medical devices), recall Z-2046-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.